ClearanceBrief
Panels › Clinical Chemistry › Product code CJE · Class 2

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Regulation 862.1050

1510(k)s in 12 months (124 all time)
0recalls in 12 months (22 all time)
22recalls that name a 510(k)
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Top companies in CJE

Company510(k)sRecalls
Pointe Scientific, Inc.,218
Em Diagnostic Systems, Inc.100
Abbott Laboratories51
Harleco50
Diagnostic Chemicals , Ltd.40
J.T. Baker Chemical Co.40
Sigma Diagnostics, Inc.40
Data Medical Associates, Inc.30
American Research Products Co.20
Beckman Instruments, Inc.20
Decided510(k)Device and applicantCode
Dec 19, 2025K251074Tru Liver Health Test Panel
Truvian Health
CJE
Oct 16, 2024K240468Alkaline Phosphatase
Abbott Laboratories Diagnostics Division
CJE
Jul 21, 2023K223317Alkaline Phosphatase2
Abbott Ireland Diagnostics Division, IE
CJE
Aug 30, 2019K191245Yumizen C1200 ALP, Yumizen C1200 Albumin
HORIBA ABX SAS, FR
CJE
Jan 25, 2018K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
Lite-On Technology Corp. H.S.P.B., TW
CJE
May 10, 2017K171080ALP IFCC Gen.2
Roche Diagnostics Operations (Rdo)
CJE
Apr 21, 2017K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Randox Laboratories Limited, GB
CJE
Aug 15, 2013K131351ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
Alfa Wassermann Diagnostic Technologies, LLC
CJE
Mar 22, 2013K130141S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
Hitachi Chemical Diagnostics, Inc.
CJE
Jul 12, 2012K113436ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
Alfa Wassermann
CJE
Dec 29, 2011K113269ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Elitechgroup
CJE
May 20, 2011K101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
Medica Corp.
CJE
Feb 28, 2008K073191ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
Thermofisher Scientific OY, FI
CJE
Jul 21, 2006K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Horiba Abx, FR
CJE
Oct 14, 2003K033185COBAS INTEGRA ALP IFCC GEN.2
Roche Diagnostics Corp.
CJE
Dec 26, 2002K023807MODIFICATION TO ALKP
Abbott Laboratories
CJE
Jan 28, 2002K013983WIENER LAB. ALP 405
Wiener Laboratories Saic, AR
CJE
Oct 9, 2001K012518TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
Thermo Dma, Inc.
CJE
Jul 20, 2001K011599ALKALINE PHOSPHATASE LIQUID REAGENT
Jas Diagnostics, Inc.
CJE
Nov 27, 2000K003093ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
Diagnostic Chemicals , Ltd., CA
CJE
Sep 26, 2000K002285ATAC PAK ALP REAGENT KIT
Elan Diagnostics
CJE
Jan 20, 2000K000067ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
Teco Diagnostics
CJE
Sep 2, 1999K991762ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
A.P. Total Care, Inc.
CJE
May 19, 1999K991387ELAN ALKALINE PHOSPHATE REAGENT KIT
Elan Holdings, Inc.
CJE
Jan 13, 1999K990024CARESIDE ALKALINE PHOSPHATASE
Careside, Inc.
CJE
Aug 26, 1998K981897ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
Roche Diagnostic Systems, Inc.
CJE
Jun 22, 1998K981806ALKP
Abbott Laboratories
CJE
May 20, 1998K981245ALKALINE PHOSPHATASE (ALKP)
Abbott Laboratories
CJE
Feb 12, 1998K980316ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
Diagnostic Chemicals , Ltd., CA
CJE
Oct 22, 1997K973588LIQUID ALKALINE PHOSHATASE REAGENT SET
Pointe Scientific, Inc.,
CJE
May 16, 1997K971463ALP REAGENT SET
Carolina Liquid Chemistries Corp.
CJE
Feb 4, 1997K964914ALKALINE PHOSPHATASE
Derma Media Lab., Inc.
CJE
Feb 28, 1996K954840ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
Sigma Diagnostics, Inc.
CJE
Nov 27, 1995K952746ALKALINE PHOSPHATASE REAGENT SYSTEM
Medical Diagnostic Technologies, Inc.
CJE
Aug 11, 1995K951584ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
Sigma Diagnostics, Inc.
CJE
Dec 29, 1994K942997ALKALINE PHOSPHATASE (ALKP) QVET
Prisma Systems
CJE
May 17, 1994K941313STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
Stanbio Laboratory
CJE
Dec 9, 1993K935182EMDS ALKANINE PHOSPHATASE (ALP) TEST
Em Diagnostic Systems, Inc.
CJE
Sep 8, 1993K931986AMP ALKALINE PHOSPHATASE REAGENT KIT
Synermed, Inc., CA
CJE
Dec 3, 1992K923507ALKALINE PHOSPHATASE KIT
Randox Laboratories, Ltd., IR
CJE
Nov 18, 1992K925156OLYMPUS ALKALINE PHOSPHATASE REAGENT
Olympus Corp.
CJE
Nov 9, 1992K924574EMDS ALKALINE PHOSPHATASE (ALP) TEST
Em Diagnostic Systems, Inc.
CJE
Sep 28, 1992K923527OLYMPUS ALKALINE PHOSPHATASE REAGENT
Olympus Corp.
CJE
Nov 22, 1991K913921ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
Em Diagnostic Systems, Inc.
CJE
Apr 12, 1991K910639SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
Em Diagnostic Systems, Inc.
CJE
Feb 13, 1991K905650KINETIC ALKALINE PHOSPHATASE DETERMINATION
Biochemical Trade, Inc.
CJE
Dec 28, 1990K905684ALKALINE PHOSPHATASE
Amresco, Inc.
CJE
Sep 27, 1990K904030SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
Synermed, Inc., CA
CJE
Jul 17, 1990K902560ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
Roche Diagnostic Systems, Inc.
CJE
Mar 1, 1990K900250AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
American Research Products Co.
CJE

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